Depomed, Inc Associate Director, Technical Operations & Mftg in Lake Forest, Illinois

City Lake Forest

State Illinois [IL]

Country United States [US]

Title Associate Director, Technical Operations & Mftg

Department Operations

Description

ESSENTIAL JOB FUNCTIONS

  • Manages and oversees tech transfer, launch, post-approval changes and routine commercial manufacturing activities at CMOs

  • Oversees and plans product needs to ensure timely supply. Assist in preparation schedules and coordination of manufacturing activities.

  • Technical leadership in Assertio products with emphasis in process and manufacturing activities.

  • Helps create a manufacturing strategy for Assertio’s products, interfacing with Quality, Clinical, and Regulatory groups.

  • Writes/reviews batch records and protocols for manufacturing of drug products.

  • Writes /reviews development and validation technical reports

  • Oversees clinical trial material manufacturing and packaging activities and manages budgets for those projects.

  • Works with Quality Systems to ensure implementation and maintenance of quality standards, meeting compliance/regulatory requirements.

  • Supports manufacturing investigations and regulatory submissions.

ADDITIONAL RESPONSIBILITIES/DUTIES

  • This position will require up to 35 % travel to contract manufacturing facilities in the US and ex-US.

Requirements

EDUCATION AND EXPERIENCE

  • BS or equivalent in Chemistry, Pharmaceutical Science, Pharmaceutical or Chemical Engineering or related field. An advanced degree in sciences would be a plus.

  • A minimum of 10 years of pharmaceutical or biotech industry experience, including late-stage development, process validation and commercial pharmaceutical cGMP manufacturing environments

  • Prior experience related to managing external CMOs is required.

  • Prior experience in working at a commercial manufacturing site is a plus

SKILLS AND ABILITIES

  • Solid problem-solving, troubleshooting and organizational skills.

  • Strong knowledge of pharmaceutical cGMPs.

  • Experience in leading cross-functional CMC teams to accomplish department goals

  • Effective communication skills (verbal, written, interpersonal, organizational), capable of setting priorities and managing high workload projects

  • Familiarity with risk management strategies

  • Ability to work strategically and independently with internal and external groups on multiple projects

DEPOMED COMPETENCIES INCLUDE

  • Integrity

  • Decisions & Judgment

  • Ownership & Initiative

  • Adaptability & Change Readiness

  • Teamwork & Collaboration

About Us

THE COMPANY

Assertio Therapeutic is a leading specialty pharmaceutical company committed to putting the Patient First in everything we do; with a focus on enhancing the lives of patients, families, physicians, providers and in payors through commercialization of products in the areas of neurology, orphan and specialty therapies.

Assertio has a clear THREE PILLAR strategy for growth:

MAINTAIN a strong/profitable NUCYNTA franchise through a commercialization agreement with Collegium, GROW the Neurology Business and BUILD a new Specialty Business through a recent Cosyntropin transaction. The company’s strategy is to continue to identify, license and develop new products-that offer enhanced therapeutic options to patient populations that may be underserved by existing therapies.

Assertio is an AA/EEO/Veterans/Disabled employer.